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Ch2:pharmacy law

manual for pharmacy technicians chapter 2

biennial inventory DEA-registered pharmacies are required by law to take an initial inventory of all controlled substances on hand upon commencing operations or upon change in ownership, with subsequent inventories conducted every 2 years thereafter.
child-resistant packaging special packaging used for hazardous products like prescription&OTC drugs&household products reducing risk of kids ingesting dangerous items by adding caps kids will have difficulty opening;all such packaging must pass test to ensure fed requirements met
controlled substances drugs/chemical substances whose possession&use are regulated under the Federal Controlled Substances Act&by state controlled substance laws®ulations. Controlled substances are subject to stricter controls than other prescription & nonprescription drugs
Drug Enforcement Administration (DEA) The federal agency that administers and enforces federal laws for controlled substances such as narcotics and other dangerous drugs and illegal substances. The DEA is part of the U.S. Department of Justice.
initial inventory the inventory a pharmacy takes of its stock of controlled substances upon beginning the dispensing or distribution of controlled substances
legend drug a drug tat is required by federal law to be dispensed by prescription only. It is the older term for drugs that are now identifies as "Rx Only".
practice of pharmacy practice of pharmacy is regulated by each state thru its pharmacy laws®ulations. The state laws®ulations establish scope of practice of pharmacy in the particular state,meaning the responsibilities pharmacists are permitted to perform in the state
state prescription monitoring programs programs implemented by the states pursuant to state laws and regulations to collect, review, and analyze information received from pharmacies about controlled substance prescriptions dispensed in the state.
state prescription monitoring programs provide information that may be reviewed by state law enforcement and regulatory agencies to assist in identifying and investigating potential improper prescribing, dispensing, and use of prescription drugs
Regulations (or Rules) issued by administrative or governmental agency establishing requirements that must be followed by the regulated persons/entities. EX=state board of pharmacy establishes qualifications a technician must meet inorder to work as a technician in that state.
if state and federal laws or regulations differ, both laws and regulations must be followed, including the more stringent requirements, whether federal or state.
State pharmacy laws do not permit pharmacy technicians to perform pharmacy tasks and responsibilities that are limited to pharmacists and require the professional judgement, education, and training of a pharmacist.
the qualifications for pharmacy technician registration or licensure generally include a minimum age, high school graduation or the equivalent, completion of a training program, including pharmacy employer training programs and an examination.
patient counseling must be provided by the pharmacist. Technicians are not authorized to counsel patients on their medications
the "orange Book" used by pharmacists to find the FDAs determination that a particular manufacturer's generic drug is therapeutically equivalent to the brand name.
Food and Drug Act (1906) Outlaws states from buying and selling food, drinks, and drugs that have been mislabeled and tainted
Sherley Amendment (1912) Outlaws labeling drugs with fake medical claims meant to trick the buyer
FDA (1930) Food and Drug Administration is named
Federal Food, Drug, and Cosmetic (FDC) Act of 1938 (1938) Requires new drugs to be proven safe prior to marketing; starts a new system of drug regulation; requires safe limits for unavoidable poisonous substances; allows for factory inspections
Durham-Humphery Amendment (1951) Defines the type of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals
Kefauver-Harris Drug Amendments (1962) Requires manufacturers to prove that their drugs are effective prior to marketing
Over-the-Counter Drug Review (1972) Nonprescription medications must be safe, effective, and appropriately labeled
tamper-Resistant Packaging Regulations (1982) Makes it a crime to tamper with packaged products and requires tamper-proof packaging
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman act)- (1984) Allowed FDA to approve generics of brand-name drugs w/o repeating research proving safety&efficacy;allowed brand-name drugs to apply for up to 5yrs of extra protection for new drugs to make up for time lost while products went thru FDA approval process
Prescription Drug Marketing Act (1988) Designed to eliminate diversion of products from legitimate channels of distribution and requires wholesalers to be licensed
Food and drug Administration Modernization Act (1997) Expands scope of agency activities and moves agency to the Department of Health and Human Services (DHHS)
Medicare Prescription Drug Improvement and Modernization Act of 2003 (2003) Includes Medicare Part D which increases access to medications through private insurers
Schedule I (CI) Controlled Substances have no accepted medical use; a high potential for abuse; and are not available by prescription
Examples of Schedule I (CI) Drugs Heroin and marijuana
Schedule II (CII) Controlled substances Have a high potential for abuse; High risk of dependence; and have FDA-approved medical uses
Examples of Schedule II (CII) Drugs Meperidine (Demerol); methadone; morphine; oxycodone (OxyIR, OxyContin), methylphenidate (Ritalin)
Schedule III (CIII) Controlled substances Moderate potential for abuse, misuse, and dependence
Examples of Schedule III (CIII) Drugs includes drug products that contain small quantities of controlled substances combined with other noncontrolled drugs such as acetaminophen and codeine (Tylenol #3) and acetaminophen and hydrocodone (Vicodin)
Schedule IV (CIV) Controlled substances low potential for abuse and limited risk of dependence
Examples of Schedule IV (CIV) Drugs Diazepam (Valium); lorazepam (Ativan); phenobarbital, and other sedatives and hypnotics
Schedule V (CV) Controlled substances lower potential for abuse, misuse, or dependence
Examples of Schedule V (CV) Drugs cough medications that combine a limited amount of codeine,anti-diarrheal medications containing a limited amount of an opiate, suc as diphenoxylate/atropine (Lomotil)
Pharmacy Technicians are permitted to do any tasks that they are permitted to do by the pharmacy laws
controlled substances are subject to stricter controls than other prescription drugs
Highest abuse potential and an accepted medical use Schedule II (CII) Controlled Substances
Products containing ephedrine or pseudoephedrine may only be kept behind the counter and sold in limited amounts
Combat Methamphetamine Epidemic Act of 2005 (CMEA) federal law that restricts the sales of ephedrine and pseudoephedrine containing OTC drugs. enacted due to continuing concerns about the use of OTC products to illegally manufacture methamphetamine or amphetamine
drug that is exception to mandatory child resistant container when dispensing (does not have to be in child resistant container) Sublingual nitroglycerin tablets
Holding a patent on a drug means no one else can produce/market that drug for the life of the patent
Generic drugs may be bioequivalent to brand name drugs, but may look different
Omnibus Budget Reconciliation Act of 1990 (OBRA '90) requires pharmacists to provide patient counseling as a condition of reimbursement when dispensing prescriptions to Medicaid patients.
Adhering to ethical principles means "doing the right thing"; complying with laws and regulations; maintaining competency; and respecting patient privacy and confidentiality
state pharmacy laws are enacted by state legislatures through the legislative process
The State Boards of Pharmacy have regulatory authority over a number of areas, including licensing pharmacies and pharmacists; registering or licensing pharmacy technicians; and disciplinary actions against pharmacies, pharmacists, and pharmacy technicians for violations of pharmacy laws and regulations.
Federal law allows Schedule III and IV prescriptions to be refilled Up to 5 times within 6 months
Schedule V prescriptions may be refilled As needed within 6 months
HIPAA Health Insurance Portability and Accountability Act
NDA new drug application
ANDA abbreviated new drug application
DAW dispense as written
DNS do not substitute
NABP National Association of Boards of Pharmacy
CMI consumer medicine information
PPI patient package insert
PHI protected health information
NACDS National Association of Chain Drug Stores
Federal law limit for pseudoephedrine products purchased within 30 day period 9grams within 30-day period
Created by: rander10



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